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Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

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NCT00743652

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Akiak, Alaska, 99552 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease, 13-valent Pneumococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42+ days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female infants 6 weeks to entire study period and reachable by phone, parents able to complete all relevant
study procedures.

- Infants who have received Prevnar are eligible to participate, but this is not
required.

- Infants participating in the blood draws must live in a specific identified area
(Yukon Kuskokwim Delta region)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any
vaccines or vaccine related components, immune deficiency, bleeding disorder or major
known congenital malformation.

NCT00743652
Pfizer
Completed
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

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[email protected]

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Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.
This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Pneumococcal Disease
  • 13-valent Pneumococcal Vaccine
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
  • Experimental: Group1
    Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 2
    Subjects <12 months of age with 1 prior dose of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 3
    Subjects <12 months of age with 2 prior doses of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 4
    Subjects ?12 months to <2 years of age.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 5
    Subjects ?2 years to <5 years of age
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
  • Infants who have received Prevnar are eligible to participate, but this is not required.
  • Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Exclusion Criteria:

  • Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.
Sexes Eligible for Study: All
42 Days to 5 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00743652
6096A1-3010
B1851009
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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